This single-center, double-blind, randomized controlled trial aims to determine whether oliceridine for patient-controlled intravenous analgesia (PCIA) can significantly reduce the incidence of postoperative nausea, an opioid-related adverse reaction, compared to sufentanil PCIA in patients undergoing cerebellopontine angle (CPA) region surgery. A secondary objective is to compare the postoperative analgesic effects between the two drugs. The study plans to enroll 174 patients (with a calculated sample size of 164 plus 5% for attrition). The primary outcome is the incidence of nausea within 6-48 hours postoperatively. Secondary outcomes include pain scores at rest and during movement within 48 hours, and other exploratory outcomes such as vomiting incidence, time to first flatus/defecation, and gastrointestinal function scores.
Scheduled for elective CPA region surgery with planned PCIA.
Age 18-65 years.
ASA physical status I-III.
Provides written informed consent.
Opioid tolerance (taking opioids ≥1 week, equivalent to oral morphine ≥50 mg/day or oxycodone ≥30 mg/day).
Severe cardiopulmonary, hepatic, renal, vascular, neurological, hematological, gastrointestinal, or endocrine diseases.
Postoperative ICU admission with tracheal intubation.
BMI ≤18.5 or ≥30 kg/m².
Parallel
Oliceridine
DrugLoading dose of 1.5 mg IV at dural closure. PCIA pump: Oliceridine 0.4 mg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min, maximum 27 mg/24h. Duration: 48h.
Sufentanil
DrugLoading dose of 7.5 mcg IV at dural closure. PCIA pump: Sufentanil 2 mcg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min. Duration: 48h.
Incidence of Postoperative Nausea
Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.
Postoperative Pain Intensity
Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement.
Incidence of Postoperative Vomiting (Clinician-Assessed Event Recording)
Occurrence of any vomiting episodes (defined as expulsion of gastric contents through the mouth or nose) within 48 hours after surgery, assessed via continuous clinical observation and bedside nursing documentation.
Severity of Nausea and Vomiting
Assessed using a Visual Analogue Scale (VAS, 0-10, where 0=no nausea and 10=worst nausea imaginable).
Use of Rescue Antiemetic Medication
Frequency and/or dose of administered rescue antiemetics (e.g., 5HT-3 receptor antagonists, metoclopramide).
Time to First Flatus
Time from end of surgery to first passage of flatus, as self-reported by the patient or directly observed and documented by nursing or study staff.
Click on the lead sponsor to view all of their trials.
